U.S. patent number 8,241,325 [Application Number 11/432,982] was granted by the patent office on 2012-08-14 for access and closure device and method.
This patent grant is currently assigned to Arstasis, Inc.. Invention is credited to D. Bruce Modesitt.
United States Patent |
8,241,325 |
Modesitt |
August 14, 2012 |
Access and closure device and method
Abstract
Devices and methods for accessing and closing vascular sites are
disclosed. Self-sealing closure devices and methods are disclosed.
A device that can make both steeply sloping and flat access paths
into a vascular lumen is disclosed. The device can also form
arteriotomies with sections cleaved between a vessel's intima and
adventitia. Methods for using the device are also disclosed.
Inventors: |
Modesitt; D. Bruce (San Carlos,
CA) |
Assignee: |
Arstasis, Inc. (Redwood City,
CA)
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Family
ID: |
37432036 |
Appl.
No.: |
11/432,982 |
Filed: |
May 12, 2006 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20060271078 A1 |
Nov 30, 2006 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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60680388 |
May 12, 2005 |
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Current U.S.
Class: |
606/215;
606/213 |
Current CPC
Class: |
A61M
25/065 (20130101); A61B 17/0057 (20130101); A61B
17/32093 (20130101); A61B 17/32 (20130101); A61B
17/34 (20130101); A61B 2017/00672 (20130101); A61M
2025/0293 (20130101); A61B 17/3468 (20130101); A61B
2017/00676 (20130101); A61B 2017/00637 (20130101); A61B
17/3421 (20130101); A61B 17/3417 (20130101); A61B
2017/00455 (20130101); A61B 2017/0065 (20130101); A61B
17/3403 (20130101); A61B 17/3415 (20130101) |
Current International
Class: |
A61B
17/08 (20060101) |
Field of
Search: |
;606/167,213,215,216,221
;604/164.01,11,158,115 |
References Cited
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PCT International Search Report and Written Opinion for
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Final Office Action for related U.S. Appl. No. 11/873,957, Inventor
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File history for related application U.S. Appl. No. 10/844,247,
filed May 12, 2004, Inventor D. Bruce Modesitt, including (211
pages total): Amendment Response to Final Office Action mailed Jul.
6, 2009, for U.S. Appl. No. 10/844,247, submitted on Dec. 7, 2009;
Examiner Interview Summary Record for U.S. Appl. No. 10/844,247,
mailed Sep. 30, 2009; Final Office Action for U.S. Appl. No.
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File history for related application U.S. Appl. No. 11/544,196,
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pages total): Terminal Disclaimer for U.S. Appl. No. 11/544,196,
submitted Mar. 18, 2011; Amendment Response to Non Final Office
Action mailed Jun. 23, 2010, for U.S. Appl. No. 11/544,196,
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File history for related application U.S. Appl. No. 11/545,272,
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pages total): Terminal Disclaimer for U.S. Appl. No. 11/545,272,
submitted Dec. 23, 2010; Amendment Response to Non Final Office
Action mailed Jun. 23, 2010, for U.S. Appl. No. 11/545,272,
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File history for related application U.S. Appl. No. 11/544,365,
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submitted Dec. 23, 2010; Amendment Response to Non Final Office
Action mailed Jun. 25, 2010, for U.S. Appl. No. 11/544,365,
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File history for related application U.S. Appl. No. 11/544,177,
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File history for related application U.S. Appl. No. 11/544,149,
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pages total): Terminal Disclaimer for U.S. Appl. No. 11/544,149,
submitted Mar. 18, 2011; Amendment Response to Non Final Office
Action mailed Jun. 24, 2010, for U.S. Appl. No. 11/544,149,
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to Final Office Action mailed Dec. 8, 2009, for U.S. Appl. No.
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Examiner Interview Summary Record for U.S. Appl. No. 11/544,149,
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No. 11/544,149, mailed Feb. 18, 2009; Preliminary Amendment for
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File history for related application U.S. Appl. No. 10/888,682,
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pages total): Supplemental Amendment Response to Final Office
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on Aug. 28, 2009 Amendment Response to Final Office Action dated
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|
Primary Examiner: McDermott; Corrine M
Assistant Examiner: Ryckman; Melissa
Attorney, Agent or Firm: Vista IP Law Group LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application claims the benefit under 35 U.S.C. .sctn.119(e) of
U.S. Provisional Application 60/680,388 filed May 12, 2005, the
content of which is incorporated herein by reference in its
entirety.
Claims
I claim:
1. A method for accessing a lumen of a vessel, the lumen defined by
a vessel wall, the method comprising: a. advancing a first elongate
member across the vessel wall to a deployed configuration wherein
at least a portion of the first elongate member occupies the lumen,
the first elongate member creating a first pathway through the
vessel wall; b. using the deployed configuration of the first
elongate member to mechanically enforce an introduction angle for
advancing a second elongate member across at least a portion of the
vessel wall; c. advancing the second elongate member across the
vessel wall to a position wherein a second pathway is created
through the vessel wall to the lumen; and d. delivering a filler
into the second pathway, wherein the filler comprises a solid
setting liquid.
2. The method of claim 1, wherein advancing the first elongate
member comprises inserting an introduction device between an outer
surface of the vessel wall and tissue surrounding the outer surface
of the vessel wall.
3. The method of claim 2, wherein the tissue surrounding the outer
surface of the vessel wall comprises adventitia.
4. The method of claim 1, wherein the first elongate member
comprises an anchor, and wherein using the deployed configuration
to mechanically enforce an introduction angle comprises using the
anchor to stabilize the second elongate member with respect to the
lumen.
5. The method of claim 4, wherein the second elongate member is
advanced through the vessel wall while the anchor stabilizes the
second elongate member with respect to the lumen.
6. The method of claim 1, wherein the second pathway is a
self-sealing pathway.
7. The method of claim 1, wherein the filler comprises an
epoxy.
8. The method of claim 1, further comprising advancing a third
elongate member through the second elongate member.
9. A method for accessing a lumen of a vessel, the lumen defined by
a vessel wall, the method comprising: a. advancing a first elongate
member across the vessel wall to a deployed configuration wherein
at least a portion of the first elongate member occupies the lumen,
the first elongate member creating a first pathway through the
vessel wall; b. using the deployed configuration of the first
elongate member to mechanically enforce an introduction angle for
advancing a second elongate member across at least a portion of the
vessel wall; c. advancing the second elongate member across the
vessel wall to a position wherein a second pathway is created
through the vessel wall to the lumen; and d. applying pressure to
the second pathway by delivering a filler adjacent to the second
pathway.
10. The method of claim 9, wherein delivering filler comprises
delivering filler into a portion of the second pathway located
between an outer surface of the vessel wall and tissue surrounding
the outer surface of the vessel wall.
11. The method of claim 9, wherein delivering filler comprises
delivering filler in the vessel wall.
12. The method of claim 9, wherein delivering filler comprises
delivering filler into tissue surrounding an outer surface of the
vessel wall.
13. The method of claim 9, further comprising advancing a third
elongate member through the second elongate member.
14. The method of claim 9, wherein the filler comprises a solid
setting liquid.
15. The method of claim 14, wherein the filler comprises an epoxy.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the field of accessing a
biological lumen and closing the access port thereby created.
2. Description of the Related Art
A number of diagnostic and interventional vascular procedures are
now performed translumenally, where a catheter is introduced to the
vascular system at a convenient access location--such as the
femoral, brachial, or subclavian arteries--and guided through the
vascular system to a target location to perform therapy or
diagnosis. When vascular access is no longer required, the catheter
and other vascular access devices must be removed from the vascular
entrance and bleeding at the puncture site must be stopped.
One common approach for providing hemostasis is to apply external
force near and upstream from the puncture site, typically by manual
compression. This method is time-consuming, frequently requiring
one-half hour or more of compression before hemostasis. This
procedure is uncomfortable for the patient and frequently requires
administering analgesics. Excessive pressure can also present the
risk of total occlusion of the blood vessel, resulting in ischemia
and/or thrombosis.
After hemostasis is achieved by manual compression, the patient is
required to remain recumbent for six to eighteen hours under
observation to assure continued hemostasis. During this time
bleeding from the vascular access wound can restart, potentially
resulting in major complications. These complications may require
blood transfusion and/or surgical intervention.
Bioabsorbable fasteners have also been used to stop bleeding.
Generally, these approaches rely on the placement of a thrombogenic
and bioabsorbable material, such as collagen, at the superficial
arterial wall over the puncture site. This method generally
presents difficulty locating the interface of the overlying tissue
and the adventitial surface of the blood vessel. Implanting the
fastener too far from the desired location can result in failure to
provide hemostasis. If, however, the fastener intrudes into the
vascular lumen, thrombus can form on the fastener. Thrombus can
embolize downstream and/or block normal blood flow at the thrombus
site. Implanted fasteners can also cause infection and auto-immune
reactions/rejections of the implant.
Suturing methods are also used to provide hemostasis after vascular
access. The suture-applying device is introduced through the tissue
tract with a distal end of the device located at the vascular
puncture. Needles in the device draw suture through the blood
vessel wall on opposite sides of the punctures, and the suture is
secured directly over the adventitial surface of the blood vessel
wall to close the vascular access wound.
To be successful, suturing methods need to be performed with a
precise control. The needles need to be properly directed through
the blood vessel wall so that the suture is well anchored in tissue
to provide for tight closure. Suturing methods also require
additional steps for the surgeon.
Due to the deficiencies of the above methods and devices, a need
exists for a more reliable vascular closure method and device.
There also exists a need for a vascular closure device and method
that is self-sealing and secure. There also exists a need for a
vascular closure device and method requiring no or few extra steps
to close the vascular site.
BRIEF SUMMARY OF THE INVENTION
A method for accessing a biological lumen having a lumen wall and
surrounding tissue is disclosed. The method includes forming a path
between the lumen wall and the surrounding tissue. The method
further includes extending the path through the lumen wall. The
method also includes opening the path to the lumen.
The method of forming the path can include inserting a device
between the lumen wall and the surrounding tissue. Extending the
path can include inserting the device through the lumen wall.
Opening the path can include inserting the device into the lumen.
The method can include delivering a filler into the path.
The method can include filling the path. Filling the path can
include delivering a filler into the path. The filler can have a
solid-setting liquid. The filler can have an epoxy.
The method can include applying pressure to the path. Applying
pressure to the path can include delivering filler adjacent to the
path. Delivering filler adjacent to the path can include delivering
filler between the lumen wall and the surrounding tissue.
Delivering filler can include delivering filler in the lumen wall.
Delivering filler can include delivering filler in the surrounding
tissue.
Also disclosed is a method for forming an arteriotomy in a lumen
having a lumen wall and surrounding tissue. The method includes
translating a device substantially between the lumen wall and the
surrounding tissue. The method further includes turning the device
toward the lumen. The method also includes translating the device
through the lumen wall. The method also includes removing the
device from the lumen wall.
The surrounding tissue can have adventitia. Turning can include
relaxation of a preformed configuration in the device.
The method can also include translating a guide through the device.
Translating a guide can include translating the guide into the
lumen. The method can also include translating a guide into the
lumen. Translating a guide can include translating the guide
through the device.
An access device for accessing a biological lumen is disclosed. The
device has an introduction device having a relaxed configuration.
The relaxed configuration has a first flat section, a first bend at
an end of the first flat section, and a first slope extending at a
first end from the first bend. The introduction device is
configured to be translated with respect to the access device.
The relaxed configuration of the introduction device can have a
second bend at a second end of the first slope, a second flat
section extending at a first end from the second bend, a third bend
at a second end of the second flat section, and a second slope
extending from the third bend. The access device can have a
delivery guide. The delivery guide can be configured to deliver the
introduction device.
The access device can have an anchor. The anchor can extend from
the delivery guide. The anchor can be configured to stabilize the
access device with respect to the lumen.
A device for accessing a biological lumen is disclosed. The
biological lumen has a lumen wall having a longitudinal lumen wall
axis. The device has an elongated member that has a longitudinal
member axis. The member is configured to access the lumen at a
first angle.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an embodiment of a method of using the arteriotomy device
in a cross-section of a lumen.
FIGS. 2 through 5 illustrate a method of using the arteriotomy
device in a cross-section of a lumen.
FIG. 6 illustrates a portion of an arteriotomized lumen.
FIGS. 7 through 11 illustrate various embodiments of section A-A of
FIG. 6.
FIG. 12 illustrates an embodiment of the arteriotomy device in a
first configuration.
FIG. 13 is a close-up view of an embodiment of section B of FIG.
12.
FIG. 14 illustrates an embodiment of the arteriotomy device of FIG.
12 in a second configuration.
FIG. 15 is a close-up view of an embodiment of section C of FIG.
14.
FIG. 16 illustrates an embodiment of the arteriotomy device of FIG.
12 in a third configuration.
FIG. 17 is a close-up view of an embodiment of section D of FIG.
16.
FIG. 18 illustrates an embodiment of the arteriotomy device of FIG.
12 in a fourth configuration.
FIG. 19 is a close-up view of an embodiment of section E of FIG.
18.
FIG. 20 illustrates an embodiment of the arteriotomy device of FIG.
12 in a fourth configuration.
FIGS. 21 and 22 are close-up views of various embodiments of
section F of FIG. 20.
FIG. 23 illustrates an embodiment of the arteriotomy device.
FIG. 24 illustrates an embodiment of the arteriotomy device of FIG.
12 in a fifth configuration.
FIG. 25 is a close-up view of an embodiment of section G of FIG.
24.
FIG. 26 illustrates an embodiment of the arteriotomy device.
FIG. 27 is a close-up view of an embodiment of section H of FIG.
26.
FIGS. 28 through 32 illustrate various embodiments of cross-section
I-I of FIG. 27.
FIGS. 33 and 34 are a perspective and side view, respectively, of
an embodiment of section H of FIG. 26.
FIG. 35 illustrates an embodiment of a method of using the
arteriotomy device in a cross-section of a lumen.
FIG. 36 is a close-up view of an embodiment of section J of FIG.
35.
FIG. 37 illustrates an embodiment of a method of using an
embodiment of the arteriotomy device of FIG. 35 in a cross-section
of a lumen.
FIG. 38 is a close-up view of an embodiment of section K of FIG.
37.
FIGS. 39 and 40 illustrate various methods of using the arteriotomy
device.
FIGS. 41 and 42 illustrate sectional views of an embodiment of the
delivery guide.
FIGS. 43 through 48 illustrate various embodiments of the
introduction device.
FIGS. 49 and 50 are various embodiments of cross-section K-K of
FIG. 48.
FIGS. 51 through 53 illustrate various embodiments of the
introduction device.
FIGS. 54 and 55 illustrate various embodiments of the introduction
device in relaxed configurations.
DETAILED DESCRIPTION
U.S. patent application Ser. No. 10/844,247, filed 12 May 2004, is
incorporated by reference herein in its entirety. Aspects,
characteristics, components or complete embodiments of devices and
methods disclosed therein can be used with anything disclosed
herein.
FIGS. 1 through 6 illustrate embodiments of an arteriotomy device
2, and methods for accessing (e.g., percutaneously) a biological
lumen 4 and deploying an introduction device 6 that can have one or
more pre-formed bends. The biological lumen 4 can be surrounded by
a lumen wall 8 (e.g., intima and/or media). The lumen wall 8 can be
surrounded by surrounding tissue 10 (e.g., media and/or
adventitia).
The arteriotomy device 2 can have a delivery guide 12. The delivery
guide 12 can be slidably attached to an anchor 14. The anchor 14
can be rigid, flexible or combinations thereof. The anchor 14 can
be resilient, deformable or combinations thereof. The anchor 14 can
be retractable and extendable from the delivery guide 12. The
anchor 14 can have a guide eye sheath or an attachable guidewire.
The anchor 14 can have an integral, or multiple separate and
fixedly attached, wound wire. The anchor 14 can have a wire
coating, for example a lubricious coating and/or a coating made
from urethane
The anchor 14 can have an anchor longitudinal axis 16. The
introduction device can have an introduction longitudinal axis 18.
The intersection of the anchor longitudinal axis 16 and the
introduction longitudinal axis 18 can be an introduction angle 20.
The anchor 14 can be inserted into the biological lumen 4 using a
Seldinger technique, modified Seldinger technique, or other method
known to one having ordinary skill in the art.
The arteriotomy device 2 can be configured to deliver the
introduction device at the introduction angle 20. The introduction
device 6 can have an introduction longitudinal axis. The
introduction angle 20 can be the intersection of the introduction
longitudinal axis 18 and the anchor longitudinal axis 16. The
introduction angle 20 can have an absolute value from about
0.degree. to about 30.degree., more narrowly from about 0.degree.
to about 19.degree., yet more narrowly from about 0.degree. to
about 15.degree., yet more narrowly from about 5.degree. to about
10.degree., for example about 10.degree..
Any or all elements of the arteriotomy device 2 or other devices or
apparatuses described herein can be made from, for example, a
single or multiple stainless steel alloys, nickel titanium alloys
(e.g., Nitinol), cobalt-chrome alloys (e.g., ELGILOY.RTM. from
Elgin Specialty Metals, Elgin, Ill.; CONICHROME.RTM. from Carpenter
Metals Corp., Wyomissing, Pa.), molybdenum alloys (e.g., molybdenum
TZM alloy, for example as disclosed in International Pub. No. WO
03/082363 A2, published Oct. 9, 2003, which is herein incorporated
by reference in its entirety), tungsten-rhenium alloys, for
example, as disclosed in International Pub. No. WO 03/082363,
polymers such as polyester (e.g., DACRON.RTM. from E. I. Du Pont de
Nemours and Company, Wilmington, Del.), carbon fiber composites
(e.g., carbon fiber nylon composite, such as carbon fiber
reinforced nylon 66), polypropylene, polytetrafluoroethylene
(PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK),
nylon, polyether-block co-polyamide polymers (e.g., PEBAX.RTM. from
ATOFINA, Paris, France), aliphatic polyether polyurethanes (e.g.,
TECOFLEX.RTM. from Thermedics Polymer Products, Wilmington, Mass.),
polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinated
ethylene propylene (FEP), absorbable or resorbable polymers such as
polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone, and
pseudo-polyamino tyrosine-based acids, extruded collagen, silicone,
zinc, echogenic, radioactive, radiopaque materials or combinations
thereof. Examples of radiopaque materials are barium sulfate, zinc
oxide, titanium, stainless steel, nickel-titanium alloys, tantalum
and gold.
Any or all elements of the arteriotomy device 2, including
supplemental closure devices, such as filler, or other devices or
apparatuses described herein can be or have a matrix for cell
ingrowth or used with a fabric, for example a covering (not shown)
that acts as a matrix for cell ingrowth. The matrix and/or fabric
can be, for example, polyester (e.g., DACRON.RTM. from E. I. du
Pont de Nemours and Company, Wilmington, Del.), polypropylene,
PTFE, ePTFE, nylon, extruded collagen, silicone or combinations
thereof.
The elements of the arteriotomy device 2 and/or the filler and/or
the fabric can be filled and/or coated with an agent delivery
matrix known to one having ordinary skill in the art and/or a
therapeutic and/or diagnostic agent. The agents within these
matrices can include radioactive materials; radiopaque materials;
cytogenic agents; cytotoxic agents; cytostatic agents; thrombogenic
agents, for example polyurethane, cellulose acetate polymer mixed
with bismuth trioxide, and ethylene vinyl alcohol; lubricious,
hydrophilic materials; phosphor cholene; anti-inflammatory agents,
for example non-steroidal anti-inflammatories (NSAIDs) such as
cyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid,
for example ASPIRIN.RTM. from Bayer AG, Leverkusen, Germany;
ibuprofen, for example ADVIL.RTM. from Wyeth, Collegeville, Pa.;
indomethacin; niefenamic acid), COX-2 inhibitors (e.g., VIOXX.RTM.
from Merck & Co., Inc., Whitehouse Station, N.J.; CELEBREX.RTM.
from Pharmacia Corp., Peapack, N.J.; COX-1 inhibitors);
immunosuppressive agents, for example Sirolimus (RAPAMUNE.RTM.,
from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP)
inhibitors (e.g., tetracycline and tetracycline derivatives) that
act early within the pathways of an inflammatory response. Examples
of other agents are provided in Walton et al, Inhibition of
Prostoglandin E.sub.2 Synthesis in Abdominal Aortic Aneurysms,
Circulation, Jul. 6, 1999, 48-54; Tambiah et al, Provocation of
Experimental Aortic Inflammation Mediators and Chlamydia
Pneumoniae, Brit. J Surgery 88 (7), 935-940; Franklin et al, Uptake
of Tetracycline by Aortic Aneurysm Wall and Its Effect on
Inflammation and Proteolysis, Brit. J Surgery 86 (6), 771-775; Xu
et al, Sp1 Increases Expression of Cyclooxygenase-2 in Hypoxic
Vascular Endothelium, J. Biological Chemistry 275 (32) 24583-24589;
and Pyo et al, Targeted Gene Disruption of Matrix
Metalloproteinase-9 (Gelatinase B) Suppresses Development of
Experimental Abdominal Aortic Aneurysms, J. Clinical Investigation
105 (11), 1641-1649 which are all incorporated by reference in
their entireties.
The delivery guide 12 can be deployed through the surrounding
tissue 10 and into the lumen wall 8 and/or the lumen 4. As
illustrated in FIGS. 45 and 46 of U.S. patent application Ser. No.
10/844,247 for a toggle deployment device, the arteriotomy device 2
can have a pressure check port. The pressure check port can be in
fluid communication with a sensor or port on or near the handle of
the arteriotomy device 2, such as an external lumen where blood
flow can be observed, for example from flow from the end of an
external tube or port and/or through a transparent or translucent
window. The pressure check port can facilitate deployment of the
arteriotomy device 2 to a location where the pressure check port is
introduced to pressure, for example when the pressure check port
enters the biological lumen 4. The sensor or port on or near the
handle of the arteriotomy device 2 will signal that the pressure
check port has been placed into the biological lumen 4 (e.g., by
displaying a small amount of blood flow). The pressure check port
can be deployed into the biological lumen 4 and then withdrawn from
the biological lumen 4 to the point where the lumen wall 8 just
stops the pressure in the pressure check port. An entry wall
retainer port can additionally perform the function as described
herein for the pressure check port.
The delivery guide 12 can form a first arteriotomy 22. When the
anchor 14 is properly located in the lumen 4, a luminal retainer 24
and/or an entry wall retainer 26 can be deployed from the anchor 14
and/or the delivery guide 12. The anchor 14, and/or luminal
retainer 24, and/or entry wall retainer 26 can be wires, rods,
inflatable balloons, or combinations thereof. The anchor 14, and/or
luminal retainer 24, and/or entry wall retainer 26 can be separate,
integral or a single component.
When the anchor 14 is properly located in the lumen 4, the
introduction device 6 can be translated, as shown by arrow. The
introduction device can form a second arteriotomy 28. The
introduction device 6 can create a cleavage 30 between the lumen
wall 8 and the surrounding tissue 10. The introduction device 6 can
cleave a plane in the lumen wall 8, as shown in FIG. 2. The
cleavage 30 and/or cleavage plane can be substantially parallel
with a lumen wall surface 32. The introduction device 6 can be
adjacent to the adventitia in a blood vessel. The introduction
device 6 can be advanced along the subintimal or submedial cleavage
plane in a blood vessel.
Once the lumen wall 8, and/or the surrounding tissue 10, and/or the
cleavage 30 has been cleaved, a subintimal angioplasty can be
performed as known to one having ordinary skill in the art. Once
the lumen wall 8, and/or the surrounding tissue 10, and/or the
cleavage 30 has been cleaved, a remote endarterectomy can be
performed as known to one having ordinary skill in the art.
The introduction device 6 can have one or more straights and/or
bends. Various bent introduction devices 34 and straight
introduction devices 36 can be swapped during use to selectively
cleave the lumen wall 8 and/or the surrounding tissue 10 and/or the
cleavage 30. Tools, such as guides (e.g., guidewires), can be
inserted through hollow introduction devices 6 to selectively
cleave.
As shown in FIG. 3, when a bend 34 in the introduction device 6
moves into the lumen wall 8, the introduction device 6 can rotate
and slope, as shown by arrow, toward the biological lumen 4. The
bend 34 in the introduction device 6 can continue to rotate the
introduction device 6 toward the biological lumen 4. When the
introduction device 6 is sloping, the introduction angle 20 can be
from about 0.degree. to about 120.degree., more narrowly from about
5.degree. to about 45.degree., yet more narrowly from about
10.degree. to about 30.degree., for example about 15.degree..
FIG. 4 illustrates that the introduction device 6 can be further
translated, as shown by arrow. The introduction device 6 can enter
the lumen 4.
The introduction device 6 can pass through an introduction run 38
and an introduction rise 40. The introduction run 38 can be the
component of the length of the introduction device 6 in the lumen
wall 8 that is parallel to the lumen wall 8. The introduction run
38 can be the component of the length parallel to the lumen wall 8
between the opening of the second arteriotomy 28 on the outside of
the lumen wall 8 and the opening of the second arteriotomy 28 on
the inside lumen wall surface 32. The introduction run 38 can be
from about 0.10 cm (0.010 in.) to about 3.810 cm (1.500 in.), for
example about 0.64 cm (0.25 in.).
The introduction rise 40 can be the component of the length of the
introduction device 6 in the lumen wall 8 that is perpendicular to
the lumen wall 8. The introduction rise 40 can be the component of
the length perpendicular to the lumen wall 8 between the opening of
the second arteriotomy 28 on the outside of the lumen wall 8 and
the opening of the second arteriotomy 28 on the inside lumen wall
surface 32. The introduction rise 40 can be from about 0.51 mm
(0.020 in.) to about 5.08 mm (0.200 in.), for example about 1.0 mm
(0.040 in.).
An introduction slope can be the ratio of the introduction rise 40
to the introduction run 38. The introduction slope can be from
about 1/2 to about 1/40 or less, for example about 1/6, also for
example about 1/3. The introduction slope can be, for examples,
equal to or less than about 1/2 or 1/3, more narrowly equal to or
less than about 1/3 or 1/4, yet more narrowly equal to or less than
about 1/5 or 1/6, even still more narrowly than about equal to or
less than about 1/10.
The introduction rise 40 and the introduction run 38 can be
components of an introduction vector. The introduction run 38 can
be the component of the introduction vector parallel to the lumen
wall 8. The introduction rise 40 can be the component of the
introduction vector perpendicular to the lumen wall 8. The
introduction vector can be a vector from an outer opening 42 to an
inner opening 44. The outer opening 42 can be a temporary or
permanent opening in the lumen wall 8 or in the surrounding tissue
10 formed by the initial translation of the introduction device 6
out of the delivery guide 12. The inner opening 44 can be a
temporary or permanent opening on the lumen wall surface 32.
FIG. 5 illustrates that the introduction device 6 can act as a
pathway for a luminal tool, for example a guidewire 46.
An introducer sheath (not shown) can be inserted over the guidewire
46 and/or over or through the introduction device 6. The introducer
sheath can be less than about 22 French (7.3 mm, 0.29 in. diameter)
or less than the diameter of the lumen to which the introducer
sheath is introduced. The introducer sheath can be, for examples,
about 6 French (2.3 mm, 0.092 in. diameter), and about 8 French
(2.67 mm, 0.105 in. diameter). The introducer sheath can be known
to one having ordinary skill in the art, for example the introducer
sheath described in U.S. Pat. No. 5,183,464 to Dubrul, et al.
The introducer sheath can be inserted into the second arteriotomy
28. The introducer sheath can expand the second arteriotomy 28 to a
desired or workable size. The introducer sheath can be inserted
into the second arteriotomy 28 before and/or after and/or
concurrently with when the filler, described infra, is deployed
and/or other closure methods or devices are used.
FIGS. 6 and 7 illustrate an exemplary biological lumen 4 after the
arteriotomy device 2 has been deployed to, and removed from, the
biological lumen 4. The biological lumen 4 can have the second
arteriotomy 28. The biological lumen 4 can have a first web 48 on
one side of the second arteriotomy 28, and a second web 50 on the
opposite side of the second arteriotomy 28. The blood pressure 52,
shown by arrows, on the first and second webs 48 and 50 can
self-seal the second arteriotomy 28.
The second arteriotomy 28 can have an arteriotomy cross-section
that can have an arteriotomy diameter 54. The arteriotomy diameter
54 can be from about 0.5 mm (0.020 in.) to about 400 mm (15 in.),
yet a narrower range from about 1.0 mm (0.040 in.) to about 10.2 mm
(0.400 in.), for example about 2.54 mm (0.100 in.). The arteriotomy
diameter 54 can be about the diameter of the introduction device
6.
The arteriotomy cross-section can be non-circular. The arteriotomy
can have an arteriotomy width and an arteriotomy height. The
arteriotomy width can be about half the circumference of the
arteriotomy. The arteriotomy width can be from about 1.0 mm (0.040
in.) to about 10.2 mm (0.400 in.), for example about 4.06 mm (0.160
in.).
The arteriotomy height 152 can be less than about 0.51 mm (0.020
in.), more narrowly, less than about 0.38 mm (0.015 in.). The
arteriotomy height can be from about 0.25 mm (0.010 in.) to about
1.3 mm (0.050 in.), for example about 0.38 mm (0.015 in.). The
arteriotomy diameter, and/or height, and/or width can be small
enough to enable cell growth, blood clotting, acoustic sealing,
heat sealing, gluing, enhanced self-sealing and combinations
thereof across the second arteriotomy 28.
The delivery guide 12 and/or other components of the arteriotomy
device 2 can form a delivery path 56 during use. During
percutaneous use, the delivery path can extend to the skin 138.
The second arteriotomy 28 can have a flat 58 and a slope 60. The
flat 58 can be the cleavage 30 between the lumen wall 8 and the
surrounding tissue.
FIG. 8 illustrates that the second arteriotomy 28 can have a first
flat 58, a first slope 64, a second flat 66, and a second slope 68.
The second arteriotomy 28 having multiple flats and slopes can be
made from one or more introduction devices 6 that can have various
geometries.
FIG. 9 illustrates that the second arteriotomy 28, for example in
the flat 58 and/or the slope 60, can be filled with a filler 70.
The filler 70 can be a solid single component, multiple solid
components (e.g., beads), a biocompatible epoxy, or combinations
thereof. The filler 70 can be completely or partially
bioabsorbable, bioresorbable, bioadsorbable or combinations
thereof. The filler 70 can be made from homografts, heterografts or
combinations thereof. The filler 70 can be made from autografts,
allografts or combinations thereof.
The filler 70 can be delivered (e.g., injected and/or implanted)
into the second arteriotomy 28 through the surrounding tissue 10,
for example by percutaneous injection. The filler 70 can be
delivered (e.g., injected and/or implanted) into the second
arteriotomy 28 through the second arteriotomy 28, for example via
the introduction device 6 during introduction and/or removal of the
introduction device 6.
The filler 70 can be permanently or temporarily deployed. The
filler 70 can biodissolve after hemostasis is achieved and/or after
the arteriotomy is substantially or completely healed. The filler
70 can be maintained from about 15 minutes to about 24 hours or
more, for example about 120 minutes.
FIG. 10 illustrates that the filler can be in the cleavage 30, not
in the second arteriotomy 28. The filler 70 can exert a filler
pressure 72 on the second arteriotomy 28, for example on the flat
58 and/or slope 60. The second arteriotomy 28 can be compressed by
the blood pressure 52 and the filler pressure 72.
FIG. 11 illustrates that the filler can be in the in the cleavage
30, not in the second arteriotomy 28. The filler 70 can exert
filler pressure 72 against the second flat 66 and/or first slope 64
and/or other sections of the second arteriotomy 28.
The filler 70 can be between the second arteriotomy 28 and the
lumen 4 (not shown). The filler 70 can be in the surrounding tissue
10.
FIGS. 12 and 13 illustrate the arteriotomy device 2. The
arteriotomy device 2 can have a handle 74 that can be integral with
or fixedly attached to a delivery guide extension 76. The delivery
guide extension 76 can be integral with or fixedly attached to the
delivery guide 12. The anchor 14 can extend from, and be slidably
and/or fixedly attached to or integral with, the delivery guide
12.
The anchor 14 can have an anchor first length 78 extending from the
delivery guide 12. The anchor 14 can have an anchor first bend 80
at the end of the first anchor length 78 distal to the delivery
guide 12. An anchor second length 82 can extend at a first end from
the anchor first bend 80. A second end of the anchor second length
82 can have an anchor second bend 84. An anchor third length 86 can
extend from the anchor second bend 84. The anchor third length 86
can terminate. The anchor 14 can have any combination of lengths
and bends.
The radius of curvature for the anchor bends 80 and 84 can be from
about 0.1 mm (0.004 in.) to about 2.0 mm (0.079 in.). The anchor
lengths on both sides of any anchor bend can form an anchoring
angle. The anchoring angles can be from about 90.degree. to about
160.degree., more narrowly from about 120.degree. to about
150.degree., for example about 135.degree.. The anchor 14 can have
a cross-section having an anchor diameter from about 0.38 mm (0.015
in.) to about 1.0 mm (0.039 in.), for example about 0.71 mm (0.028
in.).
The anchor third length 86 can have an anchor tip 88. The anchor
tip 88 can be narrowed, widened, sharpened, dulled, or otherwise
configured to promote sharp or blunt dissection. The anchor tip 88
can have an anchor end port 90. The anchor end port 90 can be in
communication with an anchor guidewire lumen (not shown). The
anchor guidewire lumen can be in communication with a guide lumen
92 in the delivery guide extension 76, and/or the handle 74, and/or
a third control 94. The guide lumen 92 can have open access along
the delivery guide extension 76, and/or along the handle 74, and/or
along the third control 94 (as shown).
The handle 74 can have a first control 96. The first control 96 can
be slidably attached to a control slide 98. The first control 96
can be configured to be ergonomically receptive to be activated a
digit and/or a palm.
The handle 74 can have a second control 100. The second control 100
can be rotatably attached to the handle 74, for example at a
control pivot 102. The second control 100 can have a tab 104. The
tab 104 can be configured to be ergonomically receptive to be
activated by a digit and/or a palm.
The handle 74 can have a third control 94. The third control can be
slidably attached to the handle 74. The third control 94 can have
or be a plunger. The third control 94 can have a press 106. The
press 106 can be configured to be ergonomically receptive to be
activated by a digit and/or a palm. The handle 74 can have one or
more grips 108. The grips 108 can be configured to be ergonomically
receptive to be held by a digit and/or a palm.
The configuration of any of the first, second or third controls 96,
100 and 94 can be any configuration (e.g., the first control can
have the rotatable lever of the second control 100).
A guidewire 46 can be in proximity to the anchor tip 88.
FIGS. 14 and 15 illustrate that the guidewire 46 can be inserted
into the anchor end port 90, as shown by arrows. The guidewire 46
can be fed through the anchor guidewire lumen and the guide lumen
92. The guidewire 46 can exit through the open section of the guide
lumen 92.
The guidewire 46 can be used to deploy the arteriotomy device to a
desired location in a lumen. The arteriotomy device 2 can be
translated, for example percutaneously, over and along the
guidewire 46. If the guidewire 46 is in a lumen, the arteriotomy
device 2 can be translated along the guidewire 46, for example,
until blood appears at the pressure check port.
FIG. 16 illustrates that the first control 96 can be activated, as
shown by arrow. The first control 96 can be translated along the
control slide 98. Activating the first control 96 can translatably
and/or rotatably deploy the luminal retainer 24, as shown by arrow
in FIG. 17.
The luminal retainer 24 can be a wire, scaffold or stent--for
example made from a deformable or resilient material, such as a
shape memory alloy--an inflatable balloon, or combinations thereof.
Intralumenal inflatable balloons, such as those inflated with
saline solution or carbon dioxide, are known to those having
ordinary skill in the art. The luminal retainer 24 can extend into
the delivery guide 12.
FIG. 17 illustrates that the luminal retainer 24 can be deployed,
as shown by arrow, for example due to the activation of the first
control 96. The luminal retainer 24 can have a first stressed
configuration. The luminal retainer 24 can have a second relaxed
configuration. The luminal retainer 24 can be in a relaxed of a
stressed configuration prior to deployment. The luminal retainer 24
can be in a relaxed or a stressed configuration after deployment.
The relaxed configuration of the luminal retainer 24 can be the
deployed configuration of the luminal retainer 24.
The luminal retainer 24 can be configured to press against the
lumen 4 during use. The luminal retainer can be deployed by
translating, rotating or a combination thereof, with respect to the
anchor 14.
The luminal retainer 24 can deploy from the anchor 14. The luminal
retainer 24 can deploy from a luminal retainer port (not shown).
The luminal retainer 24 can have a luminal retainer deployed
diameter. The luminal retainer deployed diameter can be from about
2.54 mm (0.100 in.) to about 10.2 mm (0.400 in.), for example about
6.35 mm (0.250 in.).
FIG. 18 illustrates that the second control 100 can be activated,
as shown by arrow. The second control 100 can be rotated around the
control pivot 102. Activating the second control can translatably
and/or rotatably retract the anchor 14, as shown by arrows in FIG.
19.
FIG. 19 illustrates that the anchor 14 can translate both parallel
and/or perpendicular to the delivery guide 12.
The anchor first length 78 can have an anchor shift 110 or small
inflection. The anchor shift 110 can be configured wherein the
anchor first length 78 shifts perpendicular to the longitudinal
axis of the delivery guide 12, as seen in FIG. 19. An introduction
lumen exit port 112 can be covered by the anchor first length 78,
for example, before the anchor is retracted into the delivery guide
12.
When the anchor is retracted into the delivery guide 12, an
introduction lumen exit port 112 can be exposed. When the anchor is
retracted into the delivery guide 12, the anchor shift 110,
laterally positioned compared to the rest of the anchor first
length 78, can expose the introduction lumen exit port 112. When
the anchor is retracted into the delivery guide 12, the anchor
shift 110, laterally positioned compared to the rest of the anchor
first length 78, can force the entire anchor 14 to move laterally,
thereby exposing the introduction lumen exit port 112.
FIG. 20 illustrates that the third control 94 can be activated, as
shown by arrow. The third control 94 can be translated with respect
to the handle 74. Activating the third control can translatably
deploy the introduction device 6, as shown by arrow in FIG. 21.
The introduction device 6 can have an introduction device diameter.
The introduction device diameter can be from about 0.25 mm (0.010
in.) to about 1.0 mm (0.039 in.), for example about 0.56 mm (0.022
in.).
The arteriotomy device 2 can be configured to deploy the
introduction device 6 from the anchor 14 and/or the delivery guide
12 (as shown). The anchor 14 and/or delivery guide 12 can have the
introduction lumen exit port 112. The introduction device 6 can
deploy through the introduction lumen exit port 112. The
introduction device 6 can be a solid or hollow needle, or
combinations thereof.
FIG. 22 illustrates that the distance perpendicular to the
introduction device 6 between the introduction lumen exit port 112
to the anchor first length 78 can be substantially and/or
completely equal to the introduction rise 40. The anchor 14 can
have one or more radiopaque marks. For example, the anchor first
length 78 can have a first radiopaque mark 114. The first
radiopaque mark 114 can be significantly longer along the anchor
first length 78 than the first radiopaque mark 114 is tall or wide.
The delivery guide 12 can have a second radiopaque mark 116. The
second radiopaque mark 116 can be parallel and aligned with the
path of the introduction device 6 where the introduction device 6
exits the introduction lumen exit port 112. The user can view a
radiograph or to assist in the placement of the arteriotomy device
2.
FIG. 23 illustrates that the arteriotomy device can have a first,
second and third radiopaque marks 114, 116 and 118. The first
radiopaque mark 114 can be on the handle. The second radiopaque
mark 116 can be on the delivery guide extension 76. The third
radiopaque mark 118 can be on the anchor 14. A straight alignment
axis 120 can pass through the first, second and third radiopaque
marks 114, 116 and 118. The user can utilize the alignment axis 120
to assist in the placement of the arteriotomy device 2, for example
while viewing a radiograph.
The radiopaque marks can be marks for any type of medical
imagining. For example, the marks could be sono-opaque and/or
sono-reflective for use with sonographs.
FIG. 24 illustrates that the third control 94 can be activated
further, for example, by continuing to translate the third control
94 toward the handle 74, as shown by arrow. Activating or
re-activating the third control can translatably deploy the
introduction device 6, as shown by arrow in FIG. 25.
The introduction device 6 can have a bend 34. The bend 34 can be in
a relaxed configuration of the introduction device 6. If the
introduction device 6 is deployed far enough, the bend 34 can
rotate the introduction device 6 toward the lumen 4.
The first, second and third controls 96, 100 and 94 can have
lockouts to prevent the controls 96, 100 and 94 from being
activated incorrectly (e.g., to prevent use in the wrong
order).
FIG. 26 illustrates that the luminal retainer 24 can form a
circular, oval, or spiral configuration. FIG. 27 illustrates that
the anchor 14 can have a luminal retainer exit port 122.
FIGS. 28 through 32 illustrate various configurations of the
luminal retainer 24 in the anchor 14 prior to deployment. FIG. 28
illustrates that one end of the luminal retainer can be fixedly or
rotatably attached to the anchor 14. The luminal retainer 24 can
have a ball 124 and the anchor 14 can have a socket 126. The ball
124 can have an interference fit in the socket 126. When the
deployment force is applied, shown by arrow, the luminal retainer
24 can relax, if pre-stressed (e.g., heat-treated to a specific
shape), and/or be forced into buckling out through the luminal
retainer exit port 122.
FIG. 29 illustrates that the luminal retainer 24 can be loaded in a
loop or spiral configuration in the anchor 14. When the deployment
force is applied, as shown by arrow, the loop 128 will naturally
expand and exit the luminal retainer port 122.
FIG. 30 illustrates that the luminal retainer can be pre-formed
with a curvature 130. When the deployment force is applied, shown
by arrow, the luminal retainer 24 can relax, if pre-stressed (e.g.,
heat-treated to a specific shape), and/or be forced into buckling
into the anchor 14 across from the luminal retainer exit port 122.
The luminal retainer 24 can then buckle and/or twist at the weakest
point along the length, for example the curvature 130. The luminal
retainer 24 can then exit through the luminal retainer exit port
122.
FIG. 31 illustrates that the luminal retainer 24 can be fixed to
the anchor 14, for example at a fixation area 132 (e.g., via
welding, gluing, snap fitting, etc.). FIG. 32 illustrates that the
embodiments of the luminal retainer can be reversed in direction
with respect to the remainder of the arteriotomy device 2.
FIGS. 33 and 34 illustrate that the luminal retainer 24 can deploy
as the loop or spiral. The luminal retainer 24 can deploy out of
the luminal retainer exit port 122 on the anchor (as shown) and/or
the delivery guide 12.
FIGS. 35 and 36 illustrate that arteriotomy device 2 can be
translated deep enough into the lumen 4 to contact the deployed
luminal retainer 24 against the lumen wall 8 opposite from the
arteriotomy 134. FIGS. 37 and 38 illustrate that the handle 74 can
be translated, as shown by arrow in FIG. 37, away from the lumen 4.
The luminal retainer 24 can be translated, as shown by arrow in
FIG. 38, into the lumen wall 8 closest to the arteriotomy 134. The
luminal retainer 24 can abut the lumen wall 8, for example, acting
as the entry wall retainer 26. The delivery guide extension 76 can
be rotatably attached to the delivery guide 12, for example by a
hinge 136.
FIG. 39 illustrates that the handle 74 and the delivery guide
extension 76 can rotate around the hinge, as shown by arrows, with
respect to the delivery guide 12, the anchor 14 and the luminal
retainer 24. Rotated configurations of the handle 74 and the
delivery guide extension are shown in phantom lines. The handle 74
and delivery guide extension 76 can be manipulated during use with
a minimal impact on the delivery guide 12, the anchor 14 and the
luminal retainer 24.
FIG. 40 illustrates that the delivery guide extension can be
flexible. The handle 74 and the delivery guide extension 76 can
rotate around the flexible delivery guide extension 76, as shown by
arrows, with respect to the delivery guide 12, the anchor 14 and
the luminal retainer 24. Rotated configurations of the handle 74
and the delivery guide extension are shown in phantom lines.
FIG. 41 illustrates a first longitudinal section 140 of the
delivery guide 12. FIG. 42 illustrates a second longitudinal
section 142 of the delivery guide 12. The first longitudinal
section 140 can be a complete or substantial mirror image of the
second longitudinal section 142.
An extension attachment 144 can be configured to fixedly attach to
the delivery guide extension 76. The extension abutment 146 can be
configured to abut against and/or fixedly attach to the delivery
guide extension 76. The extension attachment 144 and/or extension
abutment 146 can form fluid-tight and/or air-tight seals with the
delivery guide extension 76.
The anchor lumen 148 can be configured to receive and deploy the
anchor 14 out the anchor exit port 150. The introducer lumen 152
can be configured to receive and deploy the introduction device 6
out the introduction lumen exit port 112. The relative geometries
of the anchor lumen 148, the introducer lumen 152, the anchor exit
port 150, and the introduction lumen exit port 112 can be changed
to alter the introduction angle 20, introduction run 38,
introduction rise 40, and the geometry of the arteriotomy 134
including the geometries of the slopes 60 and flats 58 of the
arteriotomy 134.
The delivery guide half attachments 154 can attach the first
longitudinal section 140 to the second longitudinal section 142,
for example by rotatably attaching to a screw. The seam surfaces
156 of the first longitudinal section 140 can form fluid-tight
and/or air-tight seals with the seam surfaces 156 of the second
longitudinal section 142. The delivery guide tip 158 can be
sharpened, dulled, or otherwise configured to aid sharp or blunt
dissection.
FIGS. 43 through 46 illustrate solid introduction devices 6 that
can each have an introduction device shaft 160 that can terminate
in an introduction device tip 162. As shown in FIG. 43, the
introduction device tip 162 can have a centered needle point. The
introduction device tip 162 can have an introduction device tip
cross-section 164. The introduction device tip cross-section 164
can be circular or square or combinations thereof. The introduction
device tip can be curved (not shown).
FIG. 44 illustrates that the introduction device tip 162 can have
an off-center needle point. The introduction device tip
cross-section 164 can be circular or square or combinations
thereof. The introduction device 6 can be configured to have a flat
side along the introduction device shaft 160 and along the
introduction device tip 162.
FIG. 45 illustrates that the introduction device tip 162 can have a
centered chisel point. The introduction device tip cross-section
164 can be oval, rectangular, elliptical, or a combination
thereof.
FIG. 46 illustrates that the introduction device tip 162 can have a
off-centered chisel point. The introduction device tip
cross-section 164 can be oval, rectangular, elliptical, or a
combination thereof. The introduction device 6 can be configured to
have a flat side along the introduction device shaft 160 and along
the introduction device tip 162.
FIGS. 47 through 53 illustrate hollow introduction devices 6 that
can each have an introduction device shaft 160 that can terminate
in an introduction device tip 162. The introduction device shaft
160 can have a hollow guide lumen 92 than can extend to the
introduction device tip 162 or to the side of the introduction
device shaft 160. The guide lumen 92 can terminate at a guide port
166. A guide (e.g., a guidewire or other tool) can be slidably
attached to the introduction device 6 in the guide lumen 92. The
guide lumen can have a guide shaft 168 that can terminate in a
guide tip 170. The guide 172 can exit the introduction device at
the guide port 166.
As shown in FIG. 47, the introduction device tip 162 can be a
centered hollow needle point. The guide tip 170 can be a centered
needle point. The guide tip 170 can be aligned with the
introduction device tip to form a substantially smooth combined
tip.
As shown in FIG. 48, the introduction device tip 162 can be an
off-center hollow needle point. The guide tip 170 can be a centered
needle point.
FIG. 49 illustrates that the guide shaft 168 can have a key 174
and/or a slot 176 (not shown). The introduction device shaft 160
can have a slot 176 and/or a key 174 (not shown). The key 174 on
the guide shaft 168 can slidably attach to the slot 176 in the
introduction device shaft 160. The slidable attachment of the key
174 and slot 176 can prevent the guide shaft 168 from rotating
about a longitudinal axis with respect to the introduction device
shaft 160.
FIG. 50 illustrates that the guide lumen 92 and the guide shaft 168
can be oval. The oval configurations of the guide lumen 92 and the
guide shaft 168 can prevent the guide shaft 168 from rotating about
a longitudinal axis with respect to the introduction device shaft
160.
FIG. 51 illustrates that the introduction device tip 162 can have a
curved end 178. The curved end 178 can be configured to fit into a
recess 180 in the guide 172. The recess 180 can have a hook 182.
The curved end 178 can have a notch 184. The hook 182 can
interference fit and/or snap fit the notch 184.
FIG. 52 illustrates that the guide lumen 92 can be curved. The
guide lumen 92 can terminate at a guide port 166 in the side of the
introduction device shaft 160.
FIG. 53 illustrates that the introduction device tip 162 and/or the
introduction device shaft (not shown) can be curved. The guide 172
or lengths of the guide 172 can be curved in a relaxed
configuration. The guide 172 or lengths of the guide 172 can be
curved in a stressed configuration due to the curvature of the
introduction device 6.
Any of the introduction devices 6 shown in FIG. 43 through FIG. 46
can be hollowed and configured identically or similar to the
introduction devices illustrated in FIG. 47 through FIG. 53. Any of
the introduction devices 6 shown in FIG. 47 through FIG. 53 can
have no guide lumen and be configured identically or similar to the
introduction devices illustrated in FIG. 43 through FIG. 46.
The guides 172 and/or guide lumens 92 and/or introduction devices 6
can have a lubricious coating or be impregnated to elute a
lubricious material.
FIG. 54 illustrates that the introduction device 6 can have a
relaxed configuration having a flat 58 that can have a bend 34 at
one end. A slope can extend from the bend 34. The relaxed
configuration of the introduction device 6 can form the arteriotomy
configuration, for example, as shown in FIGS. 7 and 9, during
deployment of the introduction device 6 from the delivery guide
12.
FIG. 55 illustrates that the introduction device 6 can have a
relaxed configuration having a first flat 62 that can have a first
bend 186 at one end. A first slope 64 can extend at a first end
from the first bend 186. The first slope 64 can have at a second
end a second bend 188. A second flat 66 can extend at a first end
from the second bend 188. The second flat 66 can have at a second
end a third bend 190. A second slope 68 can extend from the third
bend 190. The relaxed configuration of the introduction device 6
can form the arteriotomy configuration, for example, as shown in
FIGS. 8, 10 and 11, during deployment of the introduction device 6
from the delivery guide 12.
The introduction device 6, for example a hollow introduction device
6, can act as a pathway for a luminal tool, for example tools such
as a guidewire 46, to be deployed into the lumen 4. The
introduction device 6, for example a solid introduction device 6,
can be removed from the second arteriotomy 28 and the luminal tool
can be deployed through, for example, the introduction lumen exit
port 112, and the second arteriotomy 28. The introduction device 6,
or part thereof, can be the luminal tool, for example the guide
172. The introduction device 6 can be further deployed and used as
a luminal tool after passing through the lumen wall 8.
The guide 172 can remain substantially in place after the
arteriotomy device 2 is removed. A portion of the guide 172 can be
outside the lumen 4 and another portion of the guide 172 can be
inside the lumen 4. The guide proximal end can then be attached to
additional devices and implants to guide the devices and implants
into the lumen. The filler 70 can be added after additional
procedures are completed and the guide 172 is removed, or before
the guide 172 is removed, using the guide 172 to redeploy the
arteriotomy device 2 back to the arteriotomy 134 to deliver the
filler 70.
Method of Manufacture
The elements of the arteriotomy device 2, and those of any other
devices and components disclosed herein, can be directly attached
by, for example, melting, screwing, gluing, welding or use of an
interference fit or pressure fit such as crimping, snapping, or
combining methods thereof. The elements can be integrated, for
example, molding, die cutting, laser cutting, electrical discharge
machining (EDM) or stamping from a single piece or material. Any
other methods can be used as known to those having ordinary skill
in the art.
Integrated parts can be made from pre-formed resilient materials,
for example resilient alloys (e.g., Nitinol, ELGILOY.RTM.) that are
preformed and biased into the post-deployment shape and then
compressed into the deployment shape as known to those having
ordinary skill in the art.
Any elements of the arteriotomy device 2, and those of any other
devices and components disclosed herein, including the supplemental
closure devices, as a whole after assembly, can be coated by
dip-coating, brush-coating or spray-coating methods known to one
having ordinary skill in the art.
One example of a method used to coat a medical device for vascular
use is provided in U.S. Pat. No. 6,358,556 by Ding et al. and
hereby incorporated by reference in its entirety. Time release
coating methods known to one having ordinary skill in the art can
also be used to delay the release of an agent in the coating, for
example the coatings on the supplemental closure devices.
Any elements herein can be covered with a fabric, for example
polyester (e.g., DACRON.RTM. from E. I. du Pont de Nemours and
Company, Wilmington, Del.), polypropylene, PTFE, ePTFE, nylon,
extruded collagen, silicone or combinations thereof. Methods of
covering an implantable device with fabric are known to those
having ordinary skill in the art.
As shown in FIGS. 13, 41 and 42, the delivery guide 12 can be
fixedly composited, for example with a weld, unitary construction
(e.g., by casting), snap fitting components, a screw 192, or
combinations thereof. The screw 192 can attach the delivery guide
12 to the delivery guide extension 76, for example by screwing
through the delivery guide and/or by squeezing the delivery guide
onto the delivery guide extension.
The radiopaque marks can be attached to the elements and/or coated
on the surface of the elements and/or manufactured integrally in
the elements.
The introduction device 6, guide 172, anchor 14, luminal retainer
24, entry wall retainer 26, any other elements, or combinations
thereof can be heat set in a relaxed configuration using methods
know to those having ordinary skill in the art.
It is apparent to one skilled in the art that various changes and
modifications can be made to this disclosure, and equivalents
employed, without departing from the spirit and scope of the
invention. Elements shown with any embodiment are exemplary for the
specific embodiment and can be used on other embodiments within
this disclosure.
* * * * *